Bioavailability And Bioequivalence Studies

Bioavailability And Bioequivalence Studies Each year so many drugs loss their patent protection and opens the door for the generic alternatives. In this way Bioavailability and Bioequivalence studies becomes most important. Bioavailability is defined as â€Å"The rate and extent to which the active moiety is absorbed from a drug product and becomes available at the site of action.† Bioavailability can be generally documented by a systematic exposure profile obtained by measuring drug and/metabolite concentration in the systemic circulation over a particular time period. Scope of Bioavailability studies: Development of new formulations of the already existing drugs. Determination of effect of excipients, patient related factors and possible drug To ensure the of quality of a drug product during the early stages of marketing in order to determine the influence of manufacturing factors, storage and stability factors on drug absorption. The systemic exposure profile of drug or metabolite obtained by measuring concentratio n in the systemic circulation over a particular time period during clinical trials in the early stages of drug development can serve as a benchmark for subsequent bioequivalence studies. Bioequivalence is a relative term which shows the absence of a significant difference in the rate and extent to which the active ingredient becomes available at the site of drug action when two or more identical dosage forms administered at the same molar dose under similar conditions. Bioequivalence mainly focus release of drug substances from its dosage forms and subsequent absorption into the systemic circulation i.e. test dose plasma concentration-time will be identical with reference dose plasma concentration-time without showing any significant statistical differences ,then test dosage form will consider as therapeutically equivalent to the reference dosage form . Scope of Bioequivalence studies: To establish relativity between different formulations used during the development of a new produc t. The therapeutic equivalence of a generic product and the reference product can be demonstrated. Development of a modified release form of a product which has already approved as an immediate release formulation. Development of alternative salt form for pharmaceutically equivalent drugs. Bioequivalence studies are designed to establish equivalence between the test and reference products. If test and reference products are found to be bioequivalent,by this one can expect that the test product will also be therapeutically effective. Bioanalytical method validation includes all of the procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum or urine is reliable and reproducible for the intended use. Bioanalytical method validation parameters: Accuracy Precision Selectivity Sensitivity Reproducibility Stability Validation documentation is done, by using specific laboratory investigatio ns ,which ensures that the performance characteristics of the method is suitable for the intended analytical use. The analytical method is applicable only when the validation parameters are in acceptable range. Types of validation: A. Full Validation Developing and implementing a bioanalytical method for the first time. Full validation is required for a new drug entity. If metabolites are added to an existing assay for quantification full validation is required. B. Partial Validation:

Critically discuss the importance of operations strategy to operations Essay

Critically discuss the importance of operations strategy to operations management - Essay Example It is a plan, which makes an organization utilize all available resources in an effective way. â€Å"Operational strategy begins with defining your business in terms of the present opportunity in relation to the customer and product of the business† (Wasmund 2006). Managers need to develop operations strategy by focusing many important factors, which include corporate strategy, business strategy, operational experience, and emergence sense of what ideas should included in the strategy. An operations strategy holds extreme importance in the overall organizational functions because it drives the organization towards achievement of desired goals in an efficient manner. An operations strategy needs to be comprehensive, appropriate, consistent, coherent, and all-inclusive in nature in order to move the organization towards success. Operations management includes complete processes whereas operations strategies include the plans to assist managers in the management of those processe s. The management of operational activities, which accepts inputs in order to delivers usable outputs, is called operations management (Sankaranrayanan 2011). Operations management incorporates the use of both operational strategy and operational efficiency to manage the business activities. Operational strategy includes a proper set of plans developed to achieve competitive advantage in the market.

Marketing Plan of Grace Kennedy Company Limited Term Paper

Marketing Plan of Grace Kennedy Company Limited - Term Paper Example This essay describes the Grace Kennedy Company Limited, that has been around for the past eighty-two years. The company with its staff of well over two four hundred persons sells tangible goods locally as well as internationally. The aspects of the company’s business consist of various areas. Operations, manufacturing, research, financing, personnel, marketing, business analysis and counseling, planning, presentations and project management are some of the ways by which the company fits into a number of its different aspects of business. A combination of all of these factors will help to ensure the financial success of Grace Kennedy Limited, which is its primary objective. While conducting business in a competitive market, it is to the company’s best interest that they know the competition. This knowledge will help them to better strategize their efforts. Businesses that are without competition tends to get sloppy as well as take advantage of consumers. To continue incr easing profits Grace Kennedy Company Limited should be willing to charge reasonable prices for its products. In order to develop new products for consumers, ongoing research done regularly. Because of ongoing research done in its product line, consumer needs are better able met and thus there will be an increase in sales. To create customer value, corporations should focus on the needs of individual customers as well as market segments and target industries, not product-or commodity-based priorities of the internal organization.